Description
Syneos Health is seeking a CRA II / Snr CRA - Multi Sponsor - Oncology.
The Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions they shape.
Job Responsibilities
- Performs site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
- Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site.
- Conducts Source Document Review of site source documents and medical records.
- Verifies required clinical data entered in the case report form (CRF) is accurate and complete.
- Applies query resolution techniques remotely and on-site, and provides guidance to site staff as necessary.
- May perform investigational product (IP) inventory, reconciliation, and reviews storage and security.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents.
- Supports subject/patient recruitment, retention, and awareness strategies.
- Enters data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution.
- May act as primary liaison with study site personnel or in collaboration with Central Monitoring Associate.
- Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
Qualifications
- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Must demonstrate good computer skills and be able to embrace new technologies.
- Excellent communication, presentation, and interpersonal skills.
- Ability to manage required travel of up to 75% on a regular basis.